CompletedNot Applicable

Dexamethasone Treatment for Congenital Heart Block (CHB) in Newborns With Lupus

United States150 participantsStarted 2000-10

Plain-language summary

Some newborns are born with congenital heart block (CHB), a condition occurring in babies with neonatal lupus. The first part of the study will test the effectiveness of fluorinated steroids, including dexamethasone, in improving the heart function and general health of newborns who have auto-antibody-associated CHB. The second part of this study will use ultrasound and heart monitoring to observe high-risk pregnant women and their fetuses during the third trimester of pregnancy.

Who can participate

Age range16 Years – 50 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria for Prospective Part of Trial: * Mother must have anti-Ro and/or anti-La antibody * Fetal bradyarrhythmia (slow, abnormal heart rhythm) Exclusion Criteria for Prospective Part of Trial: * Fetal heart abnormalities that may cause newborn CHB and could account for atrioventricular (AV) block Inclusion Criteria for Observational Part of Trial: * Mother must have anti-Ro and/or anti-La antibody * Fetus must have documented normal heartbeat prior to the 16th week of pregnancy * Fetus must have a structurally normal heart * Mother must be enrolled during the 16th, 17th, or 18th week of pregnancy Exclusion Criteria for Observational Part of Trial: * Mother is taking more than 10 mg of prednisone per day

What they're measuring

Neonatal ventricular heart rate

Timeframe: Measured over 5 months

Fractional shortening

Timeframe: Measured over 5 months

Abnormal fluid collection

Timeframe: Measured over 5 months

Trial details

NCT IDNCT00007358

SponsorNYU Langone Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2007-04

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